Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis With Nasal Polyps

Official title

Investigating Sinonasal Inflammatory Profiles, Histopathological Features, and Remodeling Factors in Chronic Rhinosinusitis Patients With Nasal Polyposis

Overview

This study aims to examine three key aspects of chronic rhinosinusitis with nasal polyps (CRSwNP): inflammation, tissue structure (histopathology), and remodeling.

Detailed description

By analyzing these tissue samples before and after treatment with intranasal corticosteroids (INCS), investiagtors hope to better understand how the nasal tissue changes and whether those changes are linked to improvements in symptoms. This information could help doctors create more personalized treatment plans for people with CRSwNP in the future.

Interventions

• Drug Budesonide
  Participants will use Budesonide twice daily

Primary outcome measures

• Change in sinonasal inflammatory cytokine concentrations measured in nasal secretions using multiplex immunoassay [Time frame: Baseline to 6 months]
• Change in sinonasal histopathological score assessed using semi-quantitative histopathological evaluation of nasal biopsy specimens [Time frame: Baseline to 6 months]
• Remodeling features [Time frame: 6 months]

Secondary outcome measures (2)

• SNOT-22 [Time frame: 6 months]
• Smell test [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

• Must be ≥19 of age at the time of signing the informed consent form
• Capable of giving signed informed consent.
• Having CRSwNP based on clinical symptoms and/or radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)2 and nasal polyp score (NPS) of at least 2 on each side
• Not expecting to have surgery within the next 7 months

Exclusion criteria

• A history of organ transplantation such as lung transplantation
• Previously or currently using immunomodulator or allergy medications or (including The allergy medications such as: a) First and second generations of Antihistamines (H1 blockers); b) Oral/Topical Decongestants; c) Oral or systemic corticosteroids; d) Leukotriene Receptor Antagonists; e) Mast Cell Stabilizers.

Autoimmune medications such as: a) Systemic Steroids, b) Disease-modifying antirheumatic drugs (DMARDs) (non-biologic); c) Biologics such as anti-TNF, anti-IL, anti-B cell, anti-T cell; and d) Small molecules.

• A history of auto-immune diseases such as Rheumatoid arthritis and Systemic lupus erythematosus,
• Current or past sinonasal or bronchial tumors
• Currently using systemic or oral corticosteroids (such as Prednisone, Methylprednisolone)
• Current participation in any interventional treatment trials
• Diagnosed or suspected malignant or premalignant nasal disease (e.g. Schniderian Papilloma, unilateral nasal polyposis)
• Fungal rhinosinusitis (CT/Histology), positive Aspergillus skin prick testing and/or positive Aspergillus IgE RAST (Radioallergosorbent) testing
• Malignant neoplasm within 5 years (from screening) excluding basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterinecervix treated locally and without metastatic disease for 3 years.
• Active bleeding disorders, and/or inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.
• Severe nasal deformity precluding endoscopic assessment/biopsy of postnasal space
• Have an acute or chronic infection (excluding that related to CRS) requiring management as follows:

• Currently on any treatment for a chronic infection such as pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria
• Hospitalization solely for the treatment of proven infection requiring parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1
• Proven severe infection requiring outpatient treatment with parenteral (IV or IM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 days of Day 1. Prophylactic anti-infective treatment is allowed.
• Known positive human immunodeficiency virus (HIV)\*\* status
• Known positive Hepatitis B (HB) or Hepatitis C\* status
• Having clinical evidence of significant unstable or uncontrolled acute or chronic diseases, in the opinion of the principal investigator, could confound the results of the study or put the participant at undue risk
• Have a planned surgical procedure, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the participant unsuitable for the study.
• Have received any investigational agent (that is not approved for sale in Canada) within 60 days of Day 1(Baseline visit)
• Smoking history; current or former smokers with a smoke history of packs year >15
• Subjects with parasitic (helminthic) infection Note: If there is any interested patient who is pregnant, breast-feeding or planning to get pregnant during the study period, and is interested in participation, the principal investigator will share the potential risks with them, as the drug crosses the placenta and is present in breast milk, before they decide to enroll in this study.

• As these infectious diseases induce significant and distinct changes to the immune system and inflammatory profile.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• St Paul's Sinus Centre — Vancouver

Identifiers

NCT: NCT07528820 · H25-00257

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗